US7229619B1ExpiredUtility

Methods of administering/dosing anti-RSV antibodies for prophylaxis and treatment

97
Assignee: MEDIMMUNE INCPriority: Nov 28, 2000Filed: Nov 28, 2000Granted: Jun 12, 2007
Est. expiryNov 28, 2020(expired)· nominal 20-yr term from priority
Inventors:James F. YoungScott KoenigLeslie S. JohnsonWilliam D. HuseJeffrey D. WatkinsHerren Wu
C07K 2317/24C07K 2317/56C07K 2317/565A61K 2039/505C07K 16/11
97
PatentIndex Score
114
Cited by
164
References
80
Claims

Abstract

The present invention encompasses novel antibodies and fragments thereof which immunospecifically bind to one or more RSV antigens and compositions comprising said antibodies and antibody fragments. The present invention encompasses methods preventing respiratory syncytial virus (RSV) infection in a human, comprising administering to said human a prophylactically effective amount of one or more antibodies or fragments thereof that immunospecifically bind to one or more RSV antigens, wherein a certain serum titer of said antibodies or antibody fragments is achieved in said human subject. The present invention also encompasses methods for treating or ameliorating symptoms associated with a RSV infection in a human, comprising administering to said human a therapeutically effective amount of one or more antibodies or fragments thereof that immunospecifically bind to one or more RSV antigens, wherein a certain serum titer of said antibodies or antibody fragments is achieved in said human subject. The present invention further encompasses compositions comprising antibodies or fragments thereof that immunospecifically bind to a RSV antigen, and methods using said compositions for detection or diagnosis a RSV infection.

Claims

exact text as granted — not AI-modified
1. An isolated antibody comprising a variable heavy (VH) domain having a complementarity determining region (CDR) 1 having the amino acid sequence of SEQ ID NO:10, a VH CDR2 having the amino acid sequence of SEQ ID NO:18, a VH CDR3 having the amino acid sequence of SEQ ID NO:19, and framework regions having the amino acid sequence of the VH domain framework regions depicted in  FIG. 2B  (SEQ ID NO:206), wherein said antibody immunospecifically binds to a respiratory syncytial virus (RSV) F protein. 
     
     
       2. An isolated antibody comprising a variable light (VL) domain having a CDR1 having the amino acid sequence of SEQ ID NO:21, a VL CDR2 having the amino acid sequence of SEQ ID NO:22, a VL CDR3 having the amino acid sequence of SEQ ID NO:6, and framework regions having the amino acid sequence of the VL domain framework regions depicted in  FIG. 2A  (SEQ ID NO:205), wherein said antibody immunospecifically binds to a RSV F protein. 
     
     
       3. The antibody of  claim 2  further comprising a VH domain having a CDR1 having the amino acid sequence of SEQ ID NO:10, a VH CDR2 having the amino acid sequence of SEQ ID NO:18, a VH CDR3 having the amino acid sequence of SEQ ID NO:18, a VH CDR3 having the amino acid sequence of SEQ ID NO:19, and framework regions having the amino acid sequence of the VH domain framework regions depicted in  FIG. 2B  (SEQ ID NO:206). 
     
     
       4. An isolated antibody comprising a CDR having the amino acid sequence of SEQ ID NO:10, SEQ ID NO:18 or SEQ ID NO:19, wherein said antibody immunospecifically binds to a RSV F protein. 
     
     
       5. An isolated antibody comprising a VH CDR1 having the amino acid sequence of SEQ ID NO:10, wherein said antibody immunospecifically binds to a RSV F protein. 
     
     
       6. An isolated antibody comprising a VH CDR2 having the amino acid sequence of SEQ ID NO:18, wherein said antibody immunospecifically binds to a RSV F protein. 
     
     
       7. An isolated antibody comprising a VH CDR3 having the amino acid sequence of SEQ ID NO:19, wherein said antibody immunospecifically binds to a RSV F protein. 
     
     
       8. An isolated antibody comprising a VL CDR1 having the amino acid sequence of SEQ ID NO:21, wherein said antibody immunospecifically binds to a RSV F protein. 
     
     
       9. An isolated antibody comprising a VL CDR2 having the amino acid sequence of SEQ ID NO:22, wherein said antibody immunospecifically binds to a RSV F protein. 
     
     
       10. The antibody of  claim 5 , wherein the antibody further comprises a VH CDR2 having the amino acid sequence of SEQ ID NO:18. 
     
     
       11. The antibody of  claim 5 , wherein the antibody further comprises a VH CDR3 having the amino acid sequence of SEQ ID NO:19. 
     
     
       12. The antibody of  claim 6 , wherein the antibody further comprises a VH CDR3 having the amino acid sequence of SEQ ID NO:19. 
     
     
       13. The antibody of  claim 8 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       14. The antibody of  claim 8 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       15. The antibody of  claim 9 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       16. The antibody of  claim 8 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22 and a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       17. The antibody of  claim 5 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21. 
     
     
       18. The antibody of  claim 5 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       19. The antibody of  claim 5 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       20. The antibody of  claim 6 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21. 
     
     
       21. The antibody of  claim 6 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       22. The antibody of  claim 6 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       23. The antibody of  claim 7 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21. 
     
     
       24. The antibody of  claim 7 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       25. The antibody of  claim 7 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       26. The antibody of  claim 10 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21. 
     
     
       27. The antibody of  claim 10 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       28. The antibody of  claim 10 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       29. The antibody of  claim 11 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21. 
     
     
       30. The antibody of  claim 11 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       31. The antibody of  claim 11 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       32. The antibody of  claim 12 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21. 
     
     
       33. The antibody of  claim 12 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       34. The antibody of  claim 12 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       35. The antibody of  claim 26 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       36. The antibody of  claim 27 , wherein antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       37. The antibody of  claim 29 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       38. The antibody of  claim 30 , wherein antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO: 6. 
     
     
       39. The antibody of  claim 32 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       40. The antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8 , or  9 , wherein the antibody is a monoclonal antibody. 
     
     
       41. The antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8 , or  9 , wherein the antibody is a human antibody. 
     
     
       42. The antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8 , or  9 , wherein the antibody is a humanized antibody. 
     
     
       43. The antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8 , or  9 , wherein the antibody is a chimeric antibody, single chain Fv, single chain antibody, F(ab′) 2  fragment, or Fab fragment. 
     
     
       44. The antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8 , or  9 , wherein the antibody is conjugated to a therapeutic or drug moiety. 
     
     
       45. The antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8 , or  9 , wherein the antibody is conjugated to a detectable substance. 
     
     
       46. A composition comprising the antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8 , or  9  and a pharmaceutically acceptable carrier or excipient. 
     
     
       47. A kit comprising the antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8 , or  9 , in one or more containers, and instructions for use. 
     
     
       48. The antibody of  claim 13 , wherein the antibody further comprises a VH CDR1 having the amino acid sequence of SEQ ID NO:10. 
     
     
       49. The antibody of  claim 14 , wherein the antibody further comprises a VH CDR1 having the amino acid sequence of SEQ ID NO:10. 
     
     
       50. The antibody of  claim 15 , wherein the antibody further comprises a VH CDR1 having the amino acid sequence of SEQ ID NO:10. 
     
     
       51. The antibody of  claim 16 , wherein the antibody further comprises a VH CDR1 having the amino acid sequence of SEQ ID NO:10. 
     
     
       52. The antibody of  claim 13 , wherein the antibody further comprises a VH CDR2 having the amino acid sequence of SEQ ID NO:18. 
     
     
       53. The antibody of  claim 14 , wherein the antibody further comprises a VH CDR2 having the amino acid sequence of SEQ ID NO:18. 
     
     
       54. The antibody of  claim 15 , wherein the antibody further comprises a VH CDR2 having the amino acid sequence of SEQ ID NO:18. 
     
     
       55. The antibody of  claim 16 , wherein the antibody further comprises a VH CDR2 having the amino acid sequence of SEQ ID NO:18. 
     
     
       56. The antibody of  claim 13 , wherein the antibody further comprises a VH CDR3 having the amino acid sequence of SEQ ID NO:19. 
     
     
       57. The antibody of  claim 14 , wherein the antibody further comprises a VH CDR3 having the amino acid sequence of SEQ ID NO:19. 
     
     
       58. The antibody of  claim 15 , wherein the antibody further comprises a VH CDR3 having the amino acid sequence of SEQ ID NO:19. 
     
     
       59. The antibody of  claim 16 , wherein the antibody further comprises a VH CDR3 having the amino acid sequence of SEQ ID NO:19. 
     
     
       60. The antibody of  claim 11 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21 and a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       61. The antibody of  claim 11 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21, a VL CDR2 having the amino acid sequence of SEQ ID NO:22, and a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       62. The antibody of  claim 12 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21 and a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       63. The antibody of  claim 12 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO:21, a VL CDR2 having the amino acid sequence of SEQ ID NO:22, and a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       64. An isolated antibody comprising a CDR having the amino acid sequence of a VL CDR1 or a VL CDR2 of the antibody P12F2, wherein said antibody immunospecifically binds to a RSV F protein. 
     
     
       65. The antibody of  claim 10 , wherein the antibody further comprises a VH CDR3 having the amino acid sequence of SEQ ID NO: 19. 
     
     
       66. The antibody of  claim 65 , wherein the antibody further comprises a VL CDR1 having the amino acid sequence of SEQ ID NO: 21. 
     
     
       67. The antibody of  claim 65 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       68. The antibody of  claim 65 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       69. The antibody of  claim 66 , wherein the antibody further comprises a VL CDR2 having the amino acid sequence of SEQ ID NO:22. 
     
     
       70. The antibody of  claim 66 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       71. The antibody of  claim 67 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       72. The antibody of  claim 69 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       73. The antibody of  claim 26 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       74. The antibody of  claim 35 , wherein the antibody further comprises a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       75. The antibody of  claim 33 , wherein the antibody comprises a VL CDR3 having the amino acid sequence of SEQ ID NO:6. 
     
     
       76. The composition of  claim 46  formulated for pulmonary, intranasal or parenteral administration. 
     
     
       77. The composition of  claim 46  which is a sustained release formulation. 
     
     
       78. A lyophilized formulation comprising the antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8  or  9 . 
     
     
       79. A liquid formulation comprising the antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8  or  9 . 
     
     
       80. A composition comprising the antibody of  claim 1 ,  2 ,  4 ,  5 ,  6 ,  7 ,  8  or  9 .

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